BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDNOW COVID-19

    MDR report key: 11427161 · Received March 7, 2021

    Report

    Report Number
    1221359-2021-00654
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012791 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000/ LOT:1012791, TEST BASE PART NUMBER 190-000 / LOT: 1012791 THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1012791 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT A CUMULATIVE REPORT OF THIRTY (30) FALSE NEGATIVES OVER NINE (9) LOT NUMBERS. THIS MFR. REPORT ADDRESSES LOT SIX (6) OF NINE (9). THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE TEST RESULTS ON NASAL SWABS WITH THE IDNOW COVID-19 ASSAY. CONFIRMATION TESTING ON NASAL SWABS IN VIRAL TRANSPORT MEDIA WITH (B)(6) PLATFORM GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). REFERENCE MFR. REPORTS: 1221359-2021-00642, 1221359-2021-00650, 1221359-2021-00651, 1221359-2021-00655, 1221359-2021-00656, 1221359-2021-00657, 1221359-2021-00732, 1221359-2021-00733. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012069 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT: 1012069, TEST BASE PART NUMBER 190-430 / LOT: 1012069. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1012069 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO FALSE NEGATIVE TEST RESULT USING ID NOW COVID-19 ASSAY WITH NASAL SWABS IN TRANSPORT MEDIA (B)(6) LAB PERFORMED ON (TEST DATE NOT PROVIDED). CONFIRMATION TESTING USING NASOPHARYNGEAL SWABS WITH PCR ABBOTT M2000 GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). NO PATIENT INFORMATION, HISTORY, OR IMPACT IS AVAILABLE. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND TESTED WITH AN ALTERNATIVE FDA AUTHORIZED MOLECULAR ASSAY, IF NECESSARY FOR CLINICAL MANAGEMENT, INCLUDING INFECTION CONTROL. THE PI STATES NEGATIVE RESULTS DO NOT PRECLUDE SARS-C0V-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. ADDITIONALLY, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. DUE TO THE RISK OF A POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324156 IDNOW COVID-19 MOLECULAR IVD FOR IDNOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012069

    Patients

    Seq Age Sex Outcome Treatment
    1